Breast Surgery

Investigational implant also shows lower rate of capsular contracture at two years compared to current single-lumen saline implants

New York, NY (September 10, 2012)– Women like to have options, the more options the better. Some women don’t like the look and feel of currently available saline-filled breast implants, which are prone to scalloping or wrinkling, but also aren’t comfortable with silicone gel options. An investigational breast implant, one filled with saline but with design features intended to provide a more natural result, may be just the answer they need. Results at two years with a novel, double-lumen, saline-filled breast implant, known as the IDEAL IMPLANT, reveal high patient and surgeon satisfaction, a low rate of wrinkling, and a surprisingly lower rate of capsular contracture compared to current, single-lumen, saline-filled implants. “Two-Year Outcomes With a Novel, Double-Lumen, Saline-Filled Breast Implant,” which provides full details on the two-year results of this ongoing study, appears in the September issue of the Aesthetic Surgery Journal.

“Currently available saline-filled implants have only a single lumen. This means they are essentially balloons filled with freely-moving fluid, which can result in an unnatural feel or suboptimal aesthetic result,” said co-author and clinical trial investigator Larry S. Nichter, MD, Voluntary Clinical Professor of Plastic Surgery at University of Southern California and University of California, Irvine and Chairman of the Department of Plastic Surgery at Hoag Memorial Hospital in Newport Beach, California. “The two-year clinical data from this study show that the IDEAL IMPLANT may provide a good alternative to current saline- or even silicone gel-filled implants. One of our most significant and unexpected findings was the low rate of capsular contracture for the investigational, double-lumen implant compared to current single-lumen saline implants.”

The IDEAL IMPLANT is a saline-filled breast implant with a baffle structure, two lumens, and a series of shells of increasing size nested together – a design meant to better control saline movement and provide internal support to the implant edge and upper pole. This device is being investigated in a 10-year, U.S. clinical trial evaluating safety and effectiveness in women seeking primary breast augmentation or replacement of existing augmentation implants. Two-year follow-up visits were completed by 472 of the 502 women (94.0%) enrolled at 35 private practices, 378 of whom had undergone primary breast augmentation and 94 of whom had received replacement augmentation. Patient-reported satisfaction with the outcome was 94.3% for primary augmentations and 92.3% for replacement augmentations; surgeon-reported satisfaction was also high (96.5% and 93.4%, respectively). The incidence of moderate-to-severe wrinkling was 3.8% (primary) and 12.0% (replacement). Baker Grade III and IV capsular contracture rates were 3.8% (primary) and 8.2% (replacement). These two-year rates are lower than those reported for current single-lumen saline implants at one year. Deflations, none of which were caused by a shell fold flaw, occurred in 4.8% of primary augmentations and 3.3% of replacement augmentations.

“There is a clear need for saline-filled implants that offer a more natural result for patients who don’t want silicone gel-filled devices. The early results with this new implant design appear to be very promising, particularly with regard to capsular contracture, which is always a concern with breast augmentation,” said Foad Nahai, MD, Editor-in-Chief of Aesthetic Surgery Journal. “I know that many surgeons will be interested in following up on the long-term outcomes of this study.”